FDA Adverse Event
Summary report: N
IMPLANTABLE LOOP RECORDER
MDR report key: 1182143
·
Received September 17, 2008
Report
- Report Number
- 1182143
- Date Received
- September 17, 2008
- Date of Event
- July 16, 2008
- Report Date
- September 14, 2008
- Manufacturer
- MEDTRONIC INC. CARDIAC RHYTHM DISEASE MANAGEMENT
- Product Code
- MXC
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
PATIENT HAS EXTREMELY DEBILITATING EPISODES. IN ORDER TO HELP SORT OUT HER SYMPTOM COMPLEX, SHE PREVIOUSLY UNDERWENT REVEAL INTERNAL LOOP RECORDER PLACEMENT A FEW MONTHS AGO. ON FOLLOW-UP OF HER DEVICE, IT WAS NOTED THAT IT HAD LOSS OF RECORDING WITH LONG PERIODS OF ASYSTOLE. ITWAS NOT CLEAR WHETHER THIS IS DUE TO DEVICE MALFUNCTION OR INAPPROPRIATE CONTACT. SHE WAS RECOMMENDED TO REPRESENT FOR REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANTABLE LOOP RECORDER | IMPLANTABLE ECG RECORDER | MXC | MEDTRONIC INC. CARDIAC RHYTHM DISEASE MANAGEMENT | 9528 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |